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Owlstone Medical Breath Biopsy 2.0 User Manual
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Owlstone Medical Breath Biopsy 2.0 User Manual

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2.0 Breath Biopsy
Discovery
VOC Kit
User Guide
00-0134
OW-015662-TM-3

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Summary of Contents for Owlstone Medical Breath Biopsy 2.0

  • Page 1 ® 2.0 Breath Biopsy Discovery VOC Kit User Guide 00-0134 OW-015662-TM-3...
  • Page 2 European Union countries Fragile, handle Use-by date with care Storage Temperature Humidity Limit Limit DO NOT dispose of in household waste (WEEE Directive) ©Owlstone Medical Ltd. 2018 - 2019 90-0819-003 14 SEP 2019 Page 2 of 20...

  • Page 3: Table Of Contents

    Setup of the 2.0 Breath Biopsy Discovery VOC Kit Instructions for Breath Collection Disassembly & Storage of the 2.0 Breath Biopsy Discovery VOC Kit Troubleshooting Contacts and Support ©Owlstone Medical Ltd. 2018 - 2019 90-0819-003 14 SEP 2019 Page 3 of 20...

  • Page 4: General Information

    Read and understand the various precautionary notes and symbols contained inside this manual pertaining to the safe use and operation of this product before using it. ©Owlstone Medical Ltd. 2018 - 2019 90-0819-003 14 SEP 2019 Page 4 of 20...
  • Page 5  If you encounter any problems with the equipment or this procedure, please contact Owlstone Medical Ltd immediately using the contact details in this guide. 1.3 Recycling and Disposal The Breath Biopsy Mask is a single-use only item and should be disposed of in clinical waste.

  • Page 6: Introduction To The 2.0 Breath Biopsy Discovery Voc Kit

    ReCIVA is intended for professional use only with study subjects aged 5 years or older who can follow verbal instructions. It is supplied on a business-to-business basis for research and development only. ©Owlstone Medical Ltd. 2018 - 2019 90-0819-003 14 SEP 2019 Page 6 of 20...
  • Page 7 Green Nylon, Non- Releasable, 300mm x 4.8 mm 50-0700 A4 Padded envelope 50-1358 Bubble wrap bag, 130mm x 185mm 50-1376 Clear Ziplock Bags, 230mm x 150mm (GL11) ©Owlstone Medical Ltd. 2018 - 2019 90-0819-003 14 SEP 2019 Page 7 of 20...

  • Page 8: Setup Of The 2.0 Breath Biopsy Discovery Voc Kit

    3.1 Fitting the Mask and Breath Biopsy Cartridge Assembly Ensure the work surfaces for disassembling the Breath Biopsy Cartridge and Breath Biopsy Mask are clean, free from particulates and free from chemical contamination. ©Owlstone Medical Ltd. 2018 - 2019 90-0819-003 14 SEP 2019 Page 8 of 20...
  • Page 9 When you are ready for the breath collection cut the tie wrap (if applied) holding the travel end caps on the Breath Biopsy Cartridge and then remove the travel end caps. ©Owlstone Medical Ltd. 2018 - 2019 90-0819-003 14 SEP 2019...
  • Page 10 Do not leave the tubes uncapped for more than two minutes before or after the test as they will absorb chemicals from the air in the room. ©Owlstone Medical Ltd. 2018 - 2019 90-0819-003 14 SEP 2019 Page 10 of 20...
  • Page 11 Next, put the mask and Breath Biopsy Cartridge assembly into the ReCIVA Breath Sampler, first inserting loosely into the ReCIVA. ©Owlstone Medical Ltd. 2018 - 2019 90-0819-003 14 SEP 2019 Page 11 of 20...
  • Page 12 Do NOT push the tubes in by touching the top of the tubes as this will contaminate them and the sample Finally, gently push the Breath Biopsy Mask into position ensuring it is fully seated. ©Owlstone Medical Ltd. 2018 - 2019 90-0819-003 14 SEP 2019 Page 12 of 20...

  • Page 13: Instructions For Breath Collection

    4 Instructions for Breath Collection Follow the ReCIVA Breath Sampler User Manual to collect the breath sample. ©Owlstone Medical Ltd. 2018 - 2019 90-0819-003 14 SEP 2019 Page 13 of 20...

  • Page 14: Disassembly & Storage Of The 2.0 Breath Biopsy Discovery Voc Kit

    Mask are clean, free from particulates and free from chemical contamination. The following components are single use and must not be re-used between collections:  Breath Biopsy Mask  Breath Biopsy Cartridge Assembly ©Owlstone Medical Ltd. 2018 - 2019 90-0819-003 14 SEP 2019 Page 14 of 20...
  • Page 15 This can be quite stiff. Now pull the tubes and mask (with tubes still inserted) forwards out of the ReCIVA. They should come out easily. ©Owlstone Medical Ltd. 2018 - 2019 90-0819-003 14 SEP 2019 Page 15 of 20...
  • Page 16 When they have BOTH been pushed on, at least partially, then to ensure they are fully home, push them between your palms, with fingers interlocked for more force if needed. ©Owlstone Medical Ltd. 2018 - 2019 90-0819-003 14 SEP 2019...
  • Page 17 Place the Breath Biopsy Cartridge into the 50-1358 bubble wrap bag to protect it. Place the bubble wrap bag containing the Breath Biopsy Cartridge into a 50-1376 zip lock bag. ©Owlstone Medical Ltd. 2018 - 2019 90-0819-003 14 SEP 2019 Page 17 of 20...
  • Page 18 Owlstone does not recommend storing breath samples in a freezer. When ready to ship the Breath Biopsy Cartridge, place it in the 50- 0700 A4 padded envelope. ©Owlstone Medical Ltd. 2018 - 2019 90-0819-003 14 SEP 2019 Page 18 of 20...

  • Page 19: Troubleshooting

    6 Troubleshooting Please follow the troubleshooting guides in the ReCIVA and the CASPER User Manuals. ©Owlstone Medical Ltd. 2018 - 2019 90-0819-003 14 SEP 2019 Page 19 of 20...

  • Page 20: Contacts And Support

    Milton Road technical and safe Cambridge CB4 0GJ use questions United Kingdom relating to this manual, contact us Tel: +44 (0) 1223 428200 Or email support@owlstone.com ©Owlstone Medical Ltd. 2018 - 2019 90-0819-003 14 SEP 2019 Page 20 of 20...

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00-0134